Drug product
PAPAVERINE-PHENTOLAMINE-PGE1 30-1 MG-10 MCG/ML* INJECTABLE, (a) 5ml, (b) 6ml, (c) 9ml (d) 10ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330
D-1093-2019
Product summary
- Event
- Event 82278
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13 prescription 5, 6, 9, 10 ml injection
- Official record key
drug-enforcement:D-1093-2019
Official wording
Reason: Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Code information: Lot: (a) 03102018@27, 07112018@18, 08112018@11, 16112018@15, 28112018@7, 14122018@37,16112018@41, 03012019@9, (b) 2012019@32, 23012019@59, (c)07022019@19, 07022019@1, (d)19122018@25, distributed between 09-01-2018 to 02-20-2019.
Distribution pattern: Dispensed in Oregon
Derived failure modes
-
Manufacturing or process control
Lack of Processing Controls